Pocket Mask, SP Blue (EN)

FDA UDIFDA 510(k)

Class I (US FDA UDI)

510(k) K861401

by Laerdal Medical Corp.

Identity

Trade Name: Pocket Mask, SP Blue (EN) FDA UDI
Generic Name: Cardiopulmonary resuscitation mask, reusable FDA UDI
Device Name: The Laerdal Pocket Mask is designed for mouth-to-mask ventilation of a non-breathing adult, child or infant as a barrier between the rescuer and patient. For use on an infant, the mask may be turned 180° to achieve a better seal. FDA UDI
Model / Reference: 82002133 FDA UDI
Description: The Laerdal Pocket Mask is designed for mouth-to-mask ventilation of a non-breathing adult, child or infant as a barrier between the rescuer and patient. For use on an infant, the mask may be turned 180° to achieve a better seal. FDA UDI

Identifiers

Catalog Number: 82002133 FDA UDI
Primary DI / UDI-DI: 07045432118230 FDA UDI
FDA Product Code: KGB FDA UDI
CBP FDA UDI
GMDN Term: Cardiopulmonary resuscitation mask, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 868.5570 FDA UDI
868.5870 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Cardiopulmonary resuscitation mask, reusable

Pocket Mask, SP Blue (EN) by Laerdal Medical Corp. — Class I — FDA_510K — listed in FDA GUDID, FDA 510(k) — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K861401	Class I	Active

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Manufacturer

Manufacturer: Laerdal Medical Corp.

Sources (2)

FDA UDI 0245beb2-a0b8-430a-86df-41c3ea320488 60 fields · synced Jun 19, 2026
FDA 510(k) K861401 1 fields · synced May 29, 2026